Senior Scientist, Clinical Research

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 117,000 - 184,000; Full time

Job summary

Merck is seeking a Senior Scientist, Biomarker Operations Project Management to plan and execute clinical-trial biomarkers across the pipeline, ensuring compliant biospecimen collection, assay execution, and data delivery.

The role drives operational excellence, data quality, and cross-functional collaboration with biomarker scientists, study teams, and central labs to deliver high-quality biomarker data for trials and translational research.

Qualifications

• Bachelor’s degree with 5+ years in scientific field and relevant experience.
• Master’s degree or higher with 3+ years in scientific field and relevant experience.

Responsibilities

• Plan clinical-trial biomarker set-up and logistics with study teams.
• Co-author biomarker-related sections of clinical study protocols.
• Define specimen collection, handling, shipping, storage and processing aligned to biomarker plans.
• Develop biomarker vendor statements of work and data-transfer specifications with clinical teams.
• Coordinate sample and assay logistics, issue resolution and risk mitigation with clinical teams.

Skills

Biobank

Biomarker Development

Biomarker Discovery

Biomarker Qualification

Biomarkers

Clinical Research

Drug Research

ICH GCP Guidelines

Protocol Development

Sample Handling

Education

Bachelor’s degree with 5+ years of experience

Master’s degree or higher with 3+ years of experience

Job description

Role Summary:
The Senior Scientist, Biomarker Operations Project Management is responsible for planning and executing clinical-trial biomarkers across the pipeline, ensuring compliant, efficient biospecimen collection, assay execution, and data delivery. This role drives operational excellence, data quality, and compliance across the biomarker assay project lifecycle. The Senior Scientist partners closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research. The primary focus is Immunology and Oncology; however, support of additional disease areas may be required as therapeutic focus evolves.

Job Description:
Role Summary:
The Senior Scientist, Biomarker Operations Project Management is responsible for planning and executing clinical-trial biomarkers across the pipeline, ensuring compliant, efficient biospecimen collection, assay execution, and data delivery. This role drives operational excellence, data quality, and compliance across the biomarker assay project lifecycle. The Senior Scientist partners closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research. The primary focus is Immunology and Oncology; however, support of additional disease areas may be required as therapeutic focus evolves.
Primary Activities Include, But Are Not Limited To:
Collaborate closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics, enabling efficient study execution.
Serve as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs.
Co-author biomarker-related sections of clinical study protocols.
Collaborate with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements aligned to the biomarker plan and clinical study protocol.
Develop biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams. Work with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation.
Partner with Data Management to transfer biomarker data from external vendors into the clinical data repository.
Work with clinical teams and central laboratories to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors.
Build and maintain effective partnerships with external biomarker vendors and internal teams.
Proactively identify and resolve conflicting stakeholders needs to maintain alignment and momentum.
Implement and continuously improve streamlined workflows that maximize efficiency and data quality and reinforce a culture of operational excellence.
Education:
Bachelor’s (with 5 or more years), master’s or higher (with 3 or more years) in a scientific or technological field of study and relevant experience
Experience And Skills:
Project management experience.
Experience in drug discovery and/or clinical research.
Ability to excel in fast-paced, evolving conditions and advocate for operational excellence.
Excellent written and verbal communication skills, with the ability to work within a highly collaborative, matrixed environment.
Required Skills:
Biobank, Biomarker Development, Biomarker Discovery, Biomarker Qualification, Biomarkers, Clinical Research, Drug Research, ICH GCP Guidelines, Protocol Development, Sample Handling
US And Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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The salary range for this role is
$117,000.00 - $184,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 09/11/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.
  

Requisition ID:R415344